UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057680 |
|---|---|
| Receipt number | R000065908 |
| Scientific Title | A verification study of the effects of consumption of the test food containing plant extract on male menopause and sexual function in middle-aged men: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2025/04/22 |
| Last modified on | 2025/04/22 10:51:20 |
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Basic information
Public title
A verification study of the effects of consumption of the test food containing plant extract on male menopause and sexual function in middle-aged men
Acronym
A verification study of the effects of consumption of the test food containing plant extract on male menopause and sexual function in middle-aged men
Scientific Title
A verification study of the effects of consumption of the test food containing plant extract on male menopause and sexual function in middle-aged men: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
A verification study of the effects of consumption of the test food containing plant extract on male menopause and sexual function in middle-aged men
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of four weeks of continuous consumption of the test food containing plant extract on male menopause and sexual function, and to assess its secondary effects on sex hormones and health-related quality of life, in healthy middle-aged men.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The Aging Males' Symptoms (AMS) at four weeks after intervention (4w)
Key secondary outcomes
1. The MOS Short-Form 36-Item Health Survey (SF-36) at 4w
2. Total testosterone, free testosterone, luteinizing hormone, and follicle-stimulating hormone at 4w
3. Body weight, body mass index (BMI), body fat percentage, lean body mass, fat mass (whole body, right leg, left leg, right arm, left arm, and trunk), muscle mass (whole body, right leg, left leg, right arm, left arm, and trunk), systolic blood pressure, diastolic blood pressure, waist circumference, total cholesterol (T-Cho), high density lipoprotein-cholesterol (HDL-Cho), low density lipoprotein-cholesterol (LDL-Cho), triglyceride (TG), glucose (GLU), and hemoglobin A1c (HbA1c) at 4w
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: Four weeks
Test product: Sterone power mix HC2 (Hard capsule containing black currant extract, red perilla extract, and inositol mixture)
Administration: Take two capsules per day at any time during the day
*If you forget to take the test food, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_2
Duration: Four weeks
Test product: Placebo capsule
Administration: Take two capsules per day at any time during the day
*If you forget to take the test food, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 45 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male
Key inclusion criteria
1. Japanese
2. Men
3. Individuals aged 45 or more and less than 75
4. Healthy individuals
5. Individuals whose AMS score is between 27 and 49
6. Individuals whose BMI is 23 kg/m2 or more and less than 30 kg/m2
7. Individuals whose blood concentration of total testosterone is 2.5 ng/mL or more at screening
8. Individuals whose blood concentration of free testosterone is 7.5 pg/mL or more at screening
Key exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, hepatitis B, or hepatitis C
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. Individuals who are taking or using medications (including herbal medicines) or supplements
6. Individuals who usually take foods that may affect male menopause and sexual function, such as garlic, L-arginine, zinc, or maca
7. Individuals who are allergic to medicines or foods related to the test product
8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
9. Individuals who have treatment histories of diabetes mellitus, erectile dysfunction, benign prostatic hyperplasia, gastric ulcer, psychosis, dysgeusia, or anemia within last one year
10. Individuals who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues
11. Individuals who usually drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)}
12. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
JAPAN PHARMA Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
JAPAN PHARMA Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065908
